Quinazoline derivatives are known from the prior art as active substances for example for the treatment of tumoral diseases and also diseases of the lungs and airways. Processes for preparing quinazoline derivatives are described in WO03082290 and WO07068552. WO2009098061 discloses the base (compound (II)) of the dimaleate salt according to the invention (compound (I)).
The aim of the present invention is to provide a salt of 9-[4-(3-chloro-2-fluoro-phenylamino)-7-methoxy-quinazolin-6-yloxy]-1,4-diaza-spiro[5.5]undecan-5-one which by virtue of its pharmaceutical efficacy as a tyrosine-kinase inhibitor is suitable for use in the therapeutic field, i.e. for the treatment of pathophysiological processes that are caused by the hyperfunction of tyrosine-kinases.
A further aim is to provide a compound that meets the requirements for physical and chemical stability and other properties, such as for example crystalline stability, the absence of polymorphism and low hygroscopicity, particularly with regard to the absence of polymorphism, that are imposed on an active substance of a medicament. Another aim of the present invention is to provide a stereoselective process for preparing the compound according to the invention.